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Esomeprazole magnesium enteric-coated pellets and capsules and preparation method thereof

A technology of esomeprazole magnesium enteric-coated pellets and esomeprazole magnesium, which is applied in capsule delivery, pill delivery, pharmaceutical formulations, etc., and can solve problems such as unsatisfactory effects of improving stability

Active Publication Date: 2020-01-17
湖南千金湘江药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] In addition, attempts have been made to prepare it in the form of crystals or trihydrates, however, the effect of improving stability is still unsatisfactory

Method used

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  • Esomeprazole magnesium enteric-coated pellets and capsules and preparation method thereof
  • Esomeprazole magnesium enteric-coated pellets and capsules and preparation method thereof
  • Esomeprazole magnesium enteric-coated pellets and capsules and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0080] The preparation method of esomeprazole magnesium enteric-coated pellets is as follows:

[0081] ⑴Isolation gown layer

[0082] Purpose: To isolate the sugar pill from the active ingredient layer, so that the surface of the sugar pill is smoother and rounder.

[0083] prescription:

[0084]

[0085] Preparation process: ① Weigh purified water and pour it into a container, add the above three auxiliary materials while stirring, and stir for 10-20 minutes to obtain a solution for later use.

[0086] ② Pour the medicinal pellet core into the bottom spray coating pot, set the inlet air temperature: 40-65°C, air volume:

[0087] 200-1500m 3 / h, control the liquid supply speed:

[0088] Spray liquid at 8-50rpm, dry, and increase the weight of the coating by 5%-12%.

[0089] ⑵ drug layer

[0090] Purpose: To coat the active ingredient layer.

[0091] prescription:

[0092]

[0093] Preparation process: ① Weigh purified water and pour it into a container, add esome...

Embodiment 1

[0123] Preparation of enteric-coated pellets of esomeprazole magnesium

[0124] ⑴Isolation gown layer

[0125] prescription:

[0126]

[0127] Preparation process: ① Weigh 4 kg of purified water and pour it into a container, add the above three auxiliary materials while stirring, and stir for 15 minutes to obtain a solution for later use.

[0128] ② Pour the medicinal pellet sugar core (sucrose core, 160μm average particle size) into the bottom spray coating pan, set the inlet air temperature: 40-65°C, air volume:

[0129] 800m 3 / h, control the liquid supply speed: spray liquid at 35rpm, dry, and the coating weight increases by 7.5%.

[0130] ⑵ drug layer

[0131] Purpose: To coat the active ingredient layer.

[0132] prescription:

[0133]

[0134] Preparation process: ① Weigh purified water and pour it into a container, add esomeprazole magnesium and the above two excipients while stirring, stir for 15 minutes, set aside,

[0135] ② Pour the dry coated product ...

Embodiment 2

[0164] The pellets and auxiliary materials obtained in Example 1 were mixed evenly, and compressed into tablets to prepare tablets.

[0165] prescription:

[0166]

[0167] Preparation process: Add esomeprazole magnesium enteric-coated pellets, microcrystalline cellulose, crospovidone, and polyethylene glycol into a three-dimensional mixer and mix for 15 minutes, then add magnesium stearate and mix for 5 minutes, and the Material, tablet. Made in different doses. That is, the dosage is that each tablet contains 20 mg and 40 mg of esomeprazole magnesium respectively.

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Abstract

The invention provides capsules prepared from enteric-pellets containing esomeprazole magnesium. The enteric-pellets containing the esomeprazole magnesium at least comprise hollow sugar pill cores (A), isolation coating layers (B), esomeprazole magnesium medicine layers (C) and alkaline isolation coating layers (D). By coating the esomeprazole magnesium medicine layers with the alkaline isolation coating layers, the enteric-pellets have improved stability, and then the capsules have improved stability.

Description

technical field [0001] The present invention relates to storage stable esomeprazole magnesium enteric-coated pellet capsules prepared from enteric-coated pellets containing esomeprazole magnesium and a preparation method thereof, more specifically, relates to esomeprazole magnesium from esomeprazole magnesium Esomeprazole magnesium enteric-coated micropill capsules prepared from enteric-coated pellets containing esomeprazole magnesium which are stable in storage and coated with an alkaline isolation coating layer outside the azole magnesium drug layer and its preparation method . Background technique [0002] Esomeprazole magnesium for gastroesophageal reflux disease: treatment of erosive reflux esophagitis, long-term maintenance treatment to prevent recurrence of cured esophagitis patients, symptom control of gastroesophageal reflux disease; also used It is used in combination with appropriate antimicrobial therapy to eradicate Helicobacter pylori and heal duodenal ulcers ...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K9/20A61K9/48A61K31/4439A61K47/38A61K47/10A61K47/32A61P1/04A61P31/04
Inventor 袁秀菊姚亮元郭伟钟爱军左瑾容朱颖熹尹军
Owner 湖南千金湘江药业股份有限公司
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